Maintaining Product Integrity in Biologic & Biosimilar Clinical Studies

Sponsored by: Catalent Pharma Solutions

Focused on:

  • Clinical Supply
  • Biosimilars

Date: 20 September


Time: 4PM London/11AM New York

According to an August 2016 industry study, the global biosimilars market is projected to exceed USD $28 Billion and achieve an impressive CAGR of 40.3% by 2020*. As more approved biologics near patent expiration, the race to develop and launch follow-on treatments will intensify as manufacturers strive to be the first to market with a biosimilar alternative. Delays encountered during clinical studies can have a serious impact on competitive advantage, speed to market and the availability of lower-cost alternatives for patients. While not all root causes of delays are unavoidable, many such as clinical supply disruptions can be effectively mitigated through careful strategic planning.

Specialized expertise in cold chain shipping and logistics are critical to avoid costly delays and potential for patient harm resulting from an interruption or delay in necessary clinical supply. Maintaining product integrity and reliability of supply can be especially challenging for biologic and biosimilar studies as the investigational and reference products will almost certainly require cold chain handling and may be high value, very limited in supply or require long lead times for new batches.

Clinical supply complexity increases for global studies that span a wide range of countries which may include those in cold northern latitudes to hot, humid tropical regions. Country specific import/export requirements, infrastructure and product security concerns, and variations in optimal packaging configurations and shipping lanes all have the potential to significantly impact study timing and must be carefully considered well in advance of the anticipated study start date.

Register for the webinar to learn new strategies to overcome these challenges and ensure product integrity.

*Global Biosimiliars Market - Growth, Trends & Forecasts 2014-2020
Available at: http://www.mordorintelligence.com/industry-reports/global-biosimilars-market-industry

Presented by

John Samuel,

Global Shipping Solutions Specialist

John began his career at Catalent in Deeside (North Wales) in 1995 as a Distribution Technician and progressed upwards to Distribution & Logistics Manager and held the role from 2009 to 2015 making considerable changes in developing and improving processes. In 2015 John moved into the Global CI & Technology group in the role of Global Shipping Solutions Specialist with the remit of identifying new and innovative temperature controlled packaging in order to minimise the risk of temperature excursions and improve Cold Chain shipping performance. John has also supported the Catalent business in a number of seconded roles in Singapore and Shanghai.

Mark Woolf,

Global Manager, Depot Network

Mark Woolf has recently joined Catalent as the Global Manager Depot Network. Mark has an extensive background in global distribution, including experiences at Zuellig Pharma Asia Pacific where he lived and worked in the Philippines and Almac both in the UK and USA. Mark has extensive expertise in pharmaceutical related cold chain storage and distribution which includes various operational logistic and business functions in Asia, Europe, USA, Latin America, and the Middle East. With this international logistics and operational background Mark is able to offer his experiences on the challenges faced in Clinical Trial distribution.

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Key Learning Objectives

  • Special considerations, documentation requirements and common challenges that may be encountered when importing a biologic therapy for use in a clinical study
  • Reference product sourcing and blinding strategies
  • New advances in shipping container and packaging material selection and distribution best practices for safeguarding product integrity during shipping
  • Potential benefits of using a demand led versus traditional supply model for biologic and biosimilar studies


  • Clinical Supply Director
  • Packaging Director
  • Global Sourcing Director
  • Director of Supply Chain Management
  • Director of Comparator Sourcing
  • Head of Research & Development
  • Procurement Director
  • Clinical Supplies Project Management